medical device company Articles
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A Quick Overview of ISO 13485 Requirements for Medical Device Companies
It is an undeniable fact that safety and quality are the top-most priority for medical device companies. However, the best-practices to maintain these priorities are defined under ISO 13485. You cannot brush aside the need for implementing the right enterprise quality management software to create and maintain the culture of quality and continuous improvements. The software may help you meet ...
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AngioDynamics and Cardiva Expand Partnership to Bring Life-Saving Products to More Patients in Europe
We are pleased to announce an expanded partnership with Cardiva, a Spanish-based medical device company. The partnership builds on an existing collaboration between AngioDynamics and Cardiva, which has seen the successful distribution of AngioDynamics’ vascular access portfolio in Spain and Portugal since 2012. The expanded partnership will now include AngioDynamics’ oncology ...
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Chest CT Segmentation - Case study
The challenge An industry-leading medical device company required the capability to automatically generate an accurate 3D model of complex patient-specific anatomies The anatomical model was needed for planning challenging surgical navigation procedures The pre-existing solution was slow and not robust, requiring extensive and time-consuming manual editing by the interventionist Our ...
By RSIP Vision
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Evonik Enhances Glycolide-Based Polymer Portfolio for Medical-Textile Materials
Evonik has announced the signing of an exclusive global agreement with ITV Denkendorf Produktservice (ITVP), a German-based R&D and manufacturing leader for medical-textile materials. New Platform of Glycolide-based Polymers Under the agreement, Evonik will expand its market-leading RESOMER® portfolio with the launch of a new platform of glycolide-based polymers suitable to produce ...
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Back Down Under and Racing Ahead
It has been a while since I updated this blog! Things have been extremely busy and time has flown by. So here's a very quick summary. We are delighted that Tri has continued with Cenofex Innovations as the Head of Business and Finance. We appreciate all the experience he brings to the team, and his personality and attitude are a great fit for Cenofex. We wrapped up our NSW Health-Rosenman ...
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Medical Devices: Structured Content Authoring Saves Time & Reduces Cost
Medical device companies creating technical documentation, clinical / post-marketing reports, labeling and quality documentation with increasing regulations and recent MDR/IVDR compliance in mind may find that their traditional approaches to these types of content may no longer work. The old document-based approach of creating plans/reports continuously and technical documentation does not lend ...
By DDi LLC
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Robotic Surgery: Who will be the Next Top Dog?
The competitive stakes in robotic surgery have never been higher as medical device companies try to disrupt the market that Intuitive Surgical pioneered more than two decades ago. Robotic surgery pioneer Intuitive Surgical celebrated a big milestone this week: The number of robotic-assisted procedures performed worldwide using the da Vinci surgical system has just surpassed 10 million. ...
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InfraScan Inc. Announces Publication of the Largest Study to date for TBI Diagnosis Utilizing NIRD
InfraScan, a medical device firm specializing in traumatic brain injury diagnostic products, announced the publication of the largest U.S. study to date using a near-infrared device (NIRD) to detect bleeds resulting from Traumatic Brain Injuries (TBI). This independent study was published in the Journal of Neurotrauma on 2 Aug 2022. https://doi.org/10.1089/neu.2021.0342. “We wish to thank ...
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Vicarious Surgical details its regulatory plans with FDA
Vicarious Surgical (NYSE:RBOT) announced in its quarterly earnings report that it set its FDA regulatory process in motion with a pre-submission. CEO Adam Sachs said in a news release that the robotic surgery technology developer, which just completed its first quarter as a publicly-traded company, filed a “detailed regulatory plan” in the form of a pre-submission to the FDA as it ...
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Rani Therapeutics’ $73M IPO will fund upcoming clinical trials
Rani Therapeutics, a San Jose-based company developing a pill to replace medical injections, went public on Friday. According to S-1 filings, shares were estimated to price between $14 and $16 last week. On Friday, shares debuted slightly lower, around $11. Rani raised about $73 million in its debut. Rani’s debut comes amidst a flurry of IPO activity in therapeutics. In 2020, 71 ...
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InfraScan Inc. Announces Issuance of US Patents for Brain Diagnosis
Latest patents expand near infrared platform capabilities related to trauma and stroke diagnosis InfraScan, a medical device firm specializing in brain injury and stroke diagnostic products, announced today the issuance by the US Patent Office of three additional patents that cover internal bleeding, brain trauma and stroke detection technologies. The first patent for invention number US ...
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The Medtech Big 100 is bigger than ever
The Medtech Big 100 — Medical Design & Outsourcing‘s annual revenue ranking of the world’s largest medical device companies — is growing again and the pump appears primed for more. You may recall that last year’s analysis of the industry’s 100 largest firms revealed a year-over-year drop in combined sales as the COVID-19 pandemic turned our world upside ...
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Minimally Invasive Stretta Therapy Gains Momentum as HCSC BCBS Adds Coverage for 16 Million New Patients
We’ve all been there. In our doctor’s office, or on the phone with their billing manager, being told that a drug or procedure we hoped for is not covered by our insurance plan. After weeks or even months of researching online, talking to other patients, and comparing alternatives, we’ve been told that our insurance plan simply will not cover that solution. Our frustration is ...
By Restech
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The Importance of Quality Management in the Medical Device Industry
As the world struggles to come up with a treatment for the COVID-19 virus, it’s important to remember all the amazing innovations taking place in the medical device and life sciences world: Implantable devices, like one that measures things like elevated filling pressure and weakened ventricular contraction, enabling physicians to detect risk of heart failure weeks in ...
By EtQ, LLC
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4 Quality Lessons Medical Device Manufacturers can learn from Tech Giants
Patient-centricity is a buzzword in life sciences, part of a push for innovation made difficult by complex regulations and long-standing corporate cultures that favor the status quo. Compare this to the tech industry, which is constantly developing new, high-quality products that surprise and delight customers. Companies like Apple, Google and Amazon, all of whom have pushed the limit and ...
By EtQ, LLC
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New Automated Manufacturing System Can Produce Ultra-Pure Porous Plastics
A new state-of-the-art automated manufacturing system is enabling Porvair Sciences to produce ultra-pure porous plastics that are fully compliant with FDA, USP Class VI and European Pharmacopoeia statutory regulations as well as being free from heavy metals. Kevin Doolan, General Manager of Porvair Sciences said, "Over the last 18 months we have invested significantly in specifying, testing and ...
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Meet the Entrepreneur: Carolyn Yarina and Gillian Henker, Sisu Global
At FINCA Ventures, we look for entrepreneurs leveraging market-based solutions to create large-scale, lasting social impact. In this series, “Meet the Entrepreneur,” we’ll be taking you into the minds of the intrepid leaders at our portfolio companies who boldly venture into markets in need of positive disruption. Globally, there is a shortage of over 100M units of donor blood ...
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Developing Research and Medical Diagnostic Products
The demand for research and MEDICAL DIAGNOSTIC products grows annually. Because medical diagnostic devices are used in the testing, treatment, prevention, monitoring, studying, and diagnosis of diseases and other biological human conditions, companies that develop and manufacture such diagnostic products are well positioned to serve an important and vital role in health and healthcare, the ...
By BMP Medical
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A Paradigm Shift in the Treatment of Venous Thromboembolic Disease
PE is the most common preventable cause of death among hospital patients in the United States. VTE is a leading cause of death and disability worldwide and has the third-highest mortality rate out of any cardiovascular disease, behind myocardial infarctions and stroke. Unlike myocardial infractions and stroke, where mortality has improved considerably, VTE has seen an increase in cases, with no ...
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How to Manage Concept to Production for Medical Optics
The global market for medical optical devices is continuing its steady growth and now accounts for an increasingly large proportion of the worldwide $593 billion photonics market. Optical assemblies are widely used in many areas of medical devices for all stages of diagnosis and treatment and are the key to offering more precise surgery, more accurate diagnostics and minimally invasive ...
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